MEDICATION GUIDE

FENTORA® (fen-tor-a)CII

(fentanyl buccal tablet)

100 mcg, 200 mcg, 400 mcg, 600 mcg, 800 mcg

IMPORTANT:

Do not use FENTORA unless you are regularly using another opioid pain medicine around-the-clock for your cancer pain and your body is used to these medicines (this means you are opioid tolerant). You can ask your healthcare provider if you are opioid tolerant.

Keep FENTORA in a safe place away from children.

Get emergency help right away if:

a child takes FENTORA. FENTORA can cause an overdose and death in any child who takes it.

an adult who has not been prescribed FENTORA uses it

an adult who is not already taking opioids around-the-clock, uses FENTORA.

These are medical emergencies that can cause death. If possible, try to remove FENTORA from the mouth.

Read this Medication Guide completely before you start using FENTORA, and each time you get a new prescription. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment. Share this important information with members of your household and other caregivers.

What is the most important information I should know about FENTORA?

FENTORA can cause life-threatening breathing problems which can lead to death.

1. Do not use FENTORA if you are not opioid tolerant.

2. If you stop taking your around-the-clock opioid pain medicine for your cancer pain, you must stop using FENTORA. You may no longer be opioid tolerant. Talk to your healthcare provider about how to treat your pain.

3. Use FENTORA exactly as prescribed by your healthcare provider.

You must not use more than 2 doses of FENTORA for each episode of breakthrough cancer pain.

You must wait at least 4 hours before treating a new episode of breakthrough pain with FENTORA. See the Medication Guide section “How should I use FENTORA?” and the Instructions for Use at the end of this Medication Guide for detailed information about how to use FENTORA the right way.

4. Do not switch from FENTORA to other medicines that contain fentanyl without talking with your healthcare provider. The amount of fentanyl in a dose of FENTORA is not the same as the amount of fentanyl in other medicines that contain fentanyl. Your healthcare provider will prescribe a starting dose of FENTORA that may be different than other fentanyl containing medicines you may have been taking.

5. Do not use FENTORA for short-term pain that you would expect to go away in a few days, such as:

pain after surgery

headache or migraine

dental pain

6. Never give FENTORA to anyone else, even if they have the same symptoms you have. It may harm them or even cause death.

FENTORA is a federally controlled substance (CII) because it is a strong opioid (narcotic) pain medicine that can be misused by people who abuse prescription medicines or street drugs.

Prevent theft, misuse or abuse. Keep FENTORA in a safe place to protect it from being stolen. FENTORA can be a target for people who abuse (narcotic) medicines or street drugs.

Selling or giving away this medicine is against the law.

7. FENTORA is available only through a program called the Transmucosal Immediate Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access program. To receive FENTORA, you must:

talk to your healthcare provider

understand the benefits and risks of FENTORA

agree to all of the instructions

sign the Patient-Prescriber Agreement form.

What is FENTORA?

FENTORA is a prescription medicine that contains the medicine fentanyl.

FENTORA is used to manage breakthrough pain in adults with cancer who are already routinely taking other opioid pain medicines around-the-clock for cancer pain.

FENTORA is started only after you have been taking other opioid pain medicines and your body has become used to them (you are opioid tolerant). Do not use FENTORA if you are not opioid tolerant.

You must stay under your healthcare provider’s care while using FENTORA.

FENTORA is only:

available through the TIRF REMS Access program

given to people who are opioid tolerant

It is not known if FENTORA is safe and effective in children under 18 years of age.

Who should not use FENTORA?

Do not use FENTORA:

if you are not opioid tolerant.Opioid tolerant means that you are already taking other opioid pain medicines around-the-clock for your cancer pain, and your body is used to these medicines.

for short-term pain that you would expect to go away in a few days, such as:

pain after surgery

headaches or migraines

dental pain

if you are allergic to any of the ingredients in FENTORA. See the end of this Medication Guide for a complete list of ingredients in FENTORA.

What should I tell my healthcare provider before starting FENTORA?

Before using FENTORA, tell your healthcare provider if you:

have trouble breathing or lung problems such as asthma, wheezing, or shortness of breath

have or had a head injury or brain problem

have liver or kidney problems

have seizures

have a slow heart rate or other heart problems

have low blood pressure

have mental problems including major depression, schizophrenia or hallucinations (seeing or hearing things that are not there)

have a past or present drinking problem (alcoholism), or a family history of drinking problems

have a past or present drug abuse problem or addiction problem, or a family history of a drug abuse problem or addiction problem

have any other medical conditions

are pregnant or plan to become pregnant. FENTORA may cause serious harm to your unborn baby.

are breastfeeding or plan to breastfeed. FENTORA passes into your breast milk. It can cause serious harm to your baby. You should not take FENTORA while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may cause serious or life-threatening side effects when taken with FENTORA. Sometimes, the doses of certain medicines and FENTORA need to be changed if used together.

Do not take any medicine while using FENTORA until you have talked to your healthcare provider. Your healthcare provider will tell you if it is safe to take other medicines while you are using FENTORA.

Be very careful about taking other medicines that may make you sleepy, such as other pain medicines, anti-depressant medicines, sleeping pills, anti-anxiety medicines, antihistamines, or tranquilizers.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use FENTORA?

Before you can begin to use FENTORA:

Your healthcare provider will explain the TIRF REMS Access program to you.

You will sign the TIRF REMS Access program Patient-Prescriber Agreement form.

FENTORA is only available at pharmacies that are part of the TIRF REMS Access program. Your healthcare provider will let you know the pharmacy closest to your home where you can have your FENTORA prescription filled.

Using FENTORA:

Use FENTORA exactly as prescribed.Do not use FENTORA more often than prescribed.

Your healthcare provider will change the dose until you and your healthcare provider find the right dose for you.

See the detailed Instructions for Use at the end of this Medication Guide for information about how to use FENTORA the right way.

Use FENTORA tablets whole.

Do not crush, split, suck, or chew FENTORA tablets, or swallow the tablets whole. You will get less relief for your breakthrough cancer pain.

Wait 30 minutes after using FENTORA. If there is any of the FENTORA tablet left in your mouth, you may drink a glass of water to help you swallow the left over medicine.

You must not use more than 2 doses of FENTORA for each episode of breakthrough cancer pain.

Use 1 dose of FENTORA for an episode of breakthrough cancer pain.

If your breakthrough cancer pain does not get better 30 minutes after taking the first dose of FENTORA, you can use only 1 more dose of FENTORA as instructed by your healthcare provider.

If your breakthrough pain does not get better after the second dose of FENTORA, call your healthcare provider for instructions. Do not use another dose of FENTORA at this time.

Wait at least 4 hours before treating a new episode of breakthrough cancer pain with FENTORA.

If you only need to take 1 dose of FENTORA for an episode of breakthrough pain, you must wait 4 hours from the time of that dose to take a dose of FENTORA for a new episode of breakthrough pain.

If you need to use 2 doses of FENTORA for an episode of breakthrough pain, you must wait 4 hours after the second dose to take a dose of FENTORA for a new episode of breakthrough pain.

It is important for you to keep taking your around-the-clock opioid pain medicine while using FENTORA.

Talk to your healthcare provider if your dose of FENTORA does not relieve your breakthrough cancer pain. Your healthcare provider will decide if your dose of FENTORA needs to be changed.

Talk to your healthcare provider if you have more than 4 episodes of breakthrough cancer pain per day. The dose of your around-the-clock opioid pain medicine may need to be adjusted.

If you begin to feel dizzy, sick to your stomach, or very sleepy before the tablet is completely dissolved, rinse your mouth with water and spit the remaining pieces of the tablet into a sink or toilet right away. Rinse the sink or flush the toilet to dispose of any remaining tablet pieces.

If you use too much FENTORA or overdose, you or your caregiver should call for emergency medical help or have someone take you to the nearest hospital emergency room.

What should I avoid while taking FENTORA?

Do not drive, operate heavy machinery, or do other dangerous activities until you know how FENTORA affects you. FENTORA can make you sleepy. Ask your healthcare provider when it is okay to do these activities.

Do not drink alcohol while using FENTORA. It can increase your chance of getting dangerous side effects.

What are the possible side effects of FENTORA?

FENTORA can cause serious side effects, including:

Breathing problems that can become life-threatening. See “What is the most important information I should know about FENTORA?”

Call your healthcare provider or get emergency medical help right away if you:

have trouble breathing

have drowsiness with slowed breathing

have slow, shallow breathing (little chest movement with breathing)

feel faint, very dizzy, confused, or have unusual symptoms

These symptoms can be a sign that you have taken too much FENTORA or the dose is too high for you. These symptoms may lead to serious problems or death if not treated right away. If you have any of these symptoms, do not take any more FENTORA until you have talked to your healthcare provider.

Decreased blood pressure. This can make you feel dizzy or lightheaded if you get up too fast from sitting or lying down.

Physical dependence.Do not stop using FENTORA or taking any other opioid without talking to your healthcare provider. You could become sick with uncomfortable withdrawal symptoms because your body has become used to these medicines. Physical dependency is not the same as drug addiction.

A chance of abuse or addiction. This chance is higher if you are or have been addicted to or abused other medicines, street drugs, or alcohol, or if you have a history of mental health problems.

Pain, irritation, or sores at the application site (on your gum, on the inside of your cheek, or under your tongue). Tell your healthcare provider if this is a problem for you.

The most common side effects of FENTORA are:

nausea

vomiting

dizziness

low red blood cell count

tiredness

swelling of the arms, hands, legs and feet

headache

Constipation (not often enough or hard bowel movements) is a very common side effect of pain medicines (opioids) including FENTORA and is unlikely to go away without treatment. Talk to your healthcare provider about dietary changes, and the use of laxatives (medicines to treat constipation) and stool softeners to prevent or treat constipation while taking FENTORA.

Talk to your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of FENTORA. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store FENTORA?

Always keep FENTORA in a safe place away from children and from anyone for whom it has not been prescribed. Protect FENTORA from theft.

Store FENTORA at room temperature, 59oF to 86oF (15o C to 30oC) until ready to use. Do not freeze FENTORA.

Keep FENTORA in the original blister unit. Do not remove FENTORA from its blister packaging for storage in a temporary container, such as a pill box.

Keep FENTORA dry.

How should I dispose of unused FENTORA tablets when they are no longer needed?

Dispose of any unused FENTORA tablets remaining from a prescription as soon as they are no longer needed.

Remove FENTORA tablets from blister packages and flush down the toilet.

Do not flush the FENTORA packaging (card, blister units, or cartons) down the toilet.

If you need help with disposal of FENTORA, call Teva Pharmaceuticals at 1-800-896-5855 or call your local Drug Enforcement Agency (DEA) office.

General information about FENTORA

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Use FENTORA only for the purpose for which it was prescribed. Do not give FENTORA to other people, even if they have the same symptoms you have. FENTORA can harm other people and even cause death. Sharing FENTORA is against the law.

This Medication Guide summarizes the most important information about FENTORA. If you would like more information, talk with your doctor. You can ask your pharmacist or healthcare provider for information about FENTORA that is written for health professionals.

Before you use FENTORA, it is important that you read the Medication Guide and these Instructions for Use. Be sure that you read, understand, and follow these Instructions for Use so that you use FENTORA the right way. Ask your healthcare provider or pharmacist if you have any questions about the right way to use FENTORA.

When you get an episode of breakthrough cancer pain, use the dose of FENTORA prescribed by your healthcare provider as follows:

FENTORA comes packaged as a blister card containing 4 blister units. Each blister unit contains 1 FENTORA tablet. Do not open a blister unit until ready to use.

Separate one of the blister units from the blister card by tearing apart at the perforations. Bend the blister unit along the line where indicated. The product strength of your FENTORA tablets will be printed in the boxed area shown as

(See Figure 1).

Figure 1

Peel back foil on blister unit to expose tablet (See Figure 2).

Figure 2

Do not push the tablet through the foil on the blister unit because this could damage the tablet.

When removed from the blister unit, FENTORA tablet must be used right away.

Use FENTORA tablets whole.

Do not crush, split, suck, or chew FENTORA tablets, or swallow the tablets whole. You will get less relief for your breakthrough cancer pain.

You can place a FENTORA tablet:

in your mouth above a rear molar tooth between the upper cheek and gum (See Figure 3). Switch (alternate) sides of your mouth for each dose.